Nanobody (sonelokimab) - (VELA-1)

May 10, 2026: MoonLake Immunotherapeutics (NASDAQ: MLTX) reported a positive final pre-BLA meeting (held April 1, 2026) with the FDA for sonelokimab (SLK) in hidradenitis suppurativa (HS). The FDA aligned with MoonLake on BLA submission plans and HS label strategy, reconfirmed acceptability of Phase 2 MIRA data as part of substantial evidence of effectiveness, and agreed VELA-TEEN adolescent HS data can be included as final and pivotal at BLA submission, supporting a proposed label for patients aged 12+ and an intended Priority Review request. The FDA also agreed on the safety analysis approach (primarily based on VELA-1/VELA-2) and indicated key nonclinical/CMC elements appear complete, with no remaining gaps identified.

MoonLake plans to submit the HS BLA at end of September 2026; BLA acceptance (and Priority Review decision) is expected within 60 days (by end of November 2026). The proposed HS label is expected to include MIRA ~43% HiSCR75 and ~29 percentage point delta-to-placebo at week 12.

Upcoming 2026 milestones: Q2 2026 52-week VELA-1/VELA-2 HS data; mid-2026 IZAR-1 Phase 3 PsA primary endpoint readout and VELA-TEEN primary readout; Q4 2026 IZAR-2 primary readout. Q1 2026 cash was $357.9M (runway to end of 2027).